FDA 510(k)

STERISPINE CC

K-Number: K162531 · 2016-12-29

Decision Date2016-12-29

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

STERISPINE CC is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2016-12-29 under 510(k) number K162531. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERISPINE CC?

STERISPINE CC is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is Safe Orthopaedics. The 510(k) number is K162531.

When did STERISPINE CC receive FDA 510(k) clearance?

STERISPINE CC received FDA 510(k) clearance on 2016-12-29, under 510(k) number K162531.

Who is the listed applicant for STERISPINE CC?

The FDA 510(k) record lists Safe Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERISPINE CC?

The FDA product code for STERISPINE CC is OVE.

Other records listing Safe Orthopaedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201648Sterispine™ PS K170528Sterispine™ PS

Related Devices (Code: OVE)

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.